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Trial record 1 of 1 for:    NCT03681808
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Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03681808
Recruitment Status : Completed
First Posted : September 24, 2018
Last Update Posted : May 29, 2020
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).

Condition or disease Intervention/treatment Phase
Astigmatism Device: Control Device: Test Not Applicable

Detailed Description:
This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
Masking: Single (Investigator)
Masking Description: Subjects will be dispensed product according to the treatment arm corresponding to their randomization and will be unmasked. The Investigator will be masked.
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Test
Soft Contact Lens
Device: Test
Soft Contact Lens

Active Comparator: Control
Contact lens
Device: Control
Contact Lens

Primary Outcome Measures :
  1. Corrected Distance [ Time Frame: Evaluated at the 1 week follow up visit ]
    the proportion of subjects achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
  • Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
  • Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
  • Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria:

  • Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
  • Subject has systemic disease affecting ocular health.
  • Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
  • Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03681808

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United States, California
Bausch Site 117
Irvine, California, United States, 92618
Bausch Site 107
San Diego, California, United States, 92123
Bausch Site 101
San Francisco, California, United States, 94112
Bausch Site 108
San Jose, California, United States, 95132
Bausch Site 104
Sunnyvale, California, United States, 94087
United States, Florida
Bausch Site 102
Jacksonville, Florida, United States, 32250
United States, Illinois
Bausch Site 116
Bloomington, Illinois, United States, 61701
United States, New York
Bausch Site 110
Brighton, New York, United States, 14618
Bausch Site 118
New York, New York, United States, 10022
Bausch Site 111
New York, New York, United States, 10036
United States, North Carolina
Bausch Site 114
Raleigh, North Carolina, United States, 27603
United States, Texas
Bausch Site 105
Houston, Texas, United States, 77204
United States, Washington
Bausch Site 115
Issaquah, Washington, United States, 98027
Sponsors and Collaborators
Bausch Health Americas, Inc.
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Study Director: Lindsey Mathew Bausch Health Companies
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Responsible Party: Bausch Health Americas, Inc. Identifier: NCT03681808    
Other Study ID Numbers: 885
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases